Hybrid Versus Catheter Ablation in Persistent AF

NCT02441738 | Completed DMC

• 1 other identifier: NL.52951.068.16
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of developing AF of 1 in 4 people aged over 40. Besides hemodynamic compromises stroke remains the most feared complication of AF with an increase in risk by 5-fold. Catheter ablation has evolved as a standardized treatment option in paroxysmal AF. Due to the advanced electrical and structural remodeling the single procedural results of catheter ablation for persistent and longstanding persistent AF are rather disappointing without a proven superiority of any applied strategy compared to others. However, repeated catheter ablation can achieve better results. The surgical (epicardial) approach seems to be more effective, though still a significant amount of failures exist. Checking the epicardial ablation lines and if necessary making additional endocardial lines (which is a hybrid ablation) is expected to be most efficacious in avoiding lesion gaps and providing the most complete lesion set. The study objective of this pilot trial is to compare the safety and efficacy of catheter ablation within 6 months versus a hybrid ablation consisting of endoscopic epicardial surgery combined with endocardial catheter ablation (performed one-stage) in preventing the recurrence of atrial fibrillation (AF) in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Hybrid Ablation; Catheter Ablation

Outcome Measures

Primary Outcomes (2)

• Freedom from any AT off antiarrhythmic drugs class I or III lasting > 5 minutes after the blanking period, evaluated by any ECG-tracing and 7-day holter.

  12 Months

• Major complications during follow-up

  12 Months

Study Arms (2)

Hybrid Ablation

ACTIVE COMPARATOR

Epicardial surgical ablation performed thoracoscopically with occlusion/removal of the LAA combined with percutaneous endocardial ablation (one-stage).

Procedure: Hybrid Ablation

Catheter Ablation

ACTIVE COMPARATOR

Percutaneous endocardial catheter ablation, with optional repeated catheter ablation(s).

Procedure: Catheter Ablation

Interventions

Hybrid Ablation PROCEDURE

The procedure will be performed following standard of care guidelines.

Hybrid Ablation

Catheter Ablation PROCEDURE

The procedure will be performed following standard of care guidelines.

Catheter Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Known with a history of symptomatic persistent AF or longstanding persistent atrial fibrillation,
• Refractory to or intolerant of at least one antiarrhythmic drug class I or III,
• At least 18 years of age,
• Mentally able and willing to give informed consent.

You may not qualify if:

• Previous ablation procedure,
• Longstanding persistent AF \> 3 years,
• Paroxysmal atrial fibrillation. Successful cardioversion within 48 hours of onset of the arrhythmia will be also considered paroxysmal. In patients with paroxysmal and persistent AF, the dominant pattern should be taken to categorize,
• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause,
• Presence of left atrial appendage (LAA) thrombus,
• Left atrial size ≥ 60mm (PLAX-view on TEE),
• Left ventricular ejection fraction \< 40%,
• In need for other cardiac surgery then AF treatment within 12 months,
• Intolerance to heparin and warfarin,
• Unable to undergo TEE,
• Sick-sinus-syndrome
• Mitral valve insufficiency \> Iº
• Carotic stenosis \> 80%,
• Active infection or sepsis,
• Pleural adhesions,

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

Location

Related Publications (2)

• van der Heijden CAJ, Weberndorfer V, Vroomen M, Luermans JG, Chaldoupi SM, Bidar E, Vernooy K, Maessen JG, Pison L, van Kuijk SMJ, La Meir M, Crijns HJGM, Maesen B. Hybrid Ablation Versus Repeated Catheter Ablation in Persistent Atrial Fibrillation: A Randomized Controlled Trial. JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 2):1013-1023. doi: 10.1016/j.jacep.2022.12.011. Epub 2023 Jan 18.

  PMID: 36752455 DERIVED

• Vroomen M, La Meir M, Maesen B, Luermans JGL, Vernooy K, Essers B, de Greef BTA, Maessen JG, Crijns HJ, Pison L. Hybrid thoracoscopic surgical and transvenous catheter ablation versus transvenous catheter ablation in persistent and longstanding persistent atrial fibrillation (HARTCAP-AF): study protocol for a randomized trial. Trials. 2019 Jun 20;20(1):370. doi: 10.1186/s13063-019-3365-9.

  PMID: 31221218 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Laurent Pison, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• Mark La Meir, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 12, 2015
• Study Start: October 31, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

NL (1)